The EARLY Randomized Controlled Trial (RCT) will test the finalized EARLY preventive intervention against one comparison and one control condition. Because prevention of Alcohol-exposed pregnancy (AEP) will be achieved whether woman change drinking OR contraception, the primary endpoints will be rates of risky drinking and ineffective contraception at six-month follow-up, in addition to dichotomously defined "successful outcome" that will be observed whenever a woman has sufficiently altered one or both of the behaviors that placed her at risk of Alcohol-Exposed Pregnancy (AEP). The goal is to identify a transferable intervention that effectively reduces behaviors that put women at risk for AEP and alcohol-related birth defects including FASD.

Risk for AEP is defined as the proportion of women who no longer meet the entry criteria for the trial based on her use of alcohol and unprotected intercourse, measured via the TLFB. Specifically, this means that the woman is 1) no longer at risk for pregnancy due to perfect contraception or abstinence; and/or 2) is drinking at or below recommended levels (<8drinks per week with no binges).

reports drinking more than seven standard drinks per week on average or more than one binge drinking episode (more than 3 standard drinks on one occasion) during the past 3 months

if opioid dependent with recent use, is enrolled in opiate agonist treatment

planning to remain available for the follow-up period

Exclusion Criteria:

pregnancy

cognitive disorders including mental retardation, dementia, or active -psychosis that could impair ability to understand the intervention material or give informed consent

current Major Depressive Disorder that could diminish responsiveness to interventions focused on promoting change

currently opioid dependent with active use and not engaged in opiate agonist treatment

concurrently participating in another behavioral intervention study during the study period targeting drinking or contraception efficacy that could interfere with or augment the intervention in the EARLY project.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446653